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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

New: Take the RAC Exam Online

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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UK Will Prioritize Shipments of Medicines Over Food if No-Deal Brexit Disrupts Trade

The British government has said it will prioritize medicines over food if a no-deal Brexit renders the country unable to import sufficient supplies of both. Government officials think their preparations will ensure they never need to make the decision but are clear what they will do if pushed.

Matt Hancock, the secretary of state for Health and Social Care, explained the government’s stance at a meeting of a parliamentary committee. The meeting took place after the heads of some of the UK’s leading supermarkets warned that they “anticipate significant risks to maintaining the choice, quality and durability of food” in the event of a no-deal split from the European Union.

That warning contrasts with the optimistic outlook expressed by Hancock and other people working to ensure drug supplies, leading Ben Bradshaw, a politician in the opposition Labour Party, to ask why they are confident when the food industry is pessimistic. Hancock provided the answer.

“Medicines will be prioritized in the event of a no-deal Brexit. Of course medicines should get priority over food,” the government minister said. “The proportion of food that is imported is much smaller than for medicines. Around half [of medicines] have some touchpoint with the EU and therefore need a plan to mitigate the challenges ... in the event of significant disruptions at the border.”

It remains unclear whether the UK will need to activate those contingency plans. Politicians in the UK spent this week discussing and voting on amendments designed to redefine the terms of the Brexit agreement, leading to the passage of a text that tasks Prime Minister Theresa May with renegotiating the backstop agreement with the EU. Minutes after the amendment passed, the EU reiterated its unwillingness to renegotiate the backstop.

Whatever happens, Hancock and his collaborators think medicine suppliers will continue, although the wording of their statements show there are limits to what they can guarantee unilaterally.

“Provided everybody does what they’re supposed to do — particularly the transport infrastructure, we’re completely reliant on the Department for Transport — then we would expect the availability of those supplies to continue,” Simon Stevens, chief executive of NHS England, told the committee.

Other NHS leaders are less confident. This week, David Rosser, chief executive of University Hospitals Birmingham NHS Foundation Trust, issued a memo stating, “Many NHS trusts could quickly run out of vital medical supplies” in the event of a no-deal Brexit. Rosser based the warning on feedback from “well informed and non-political NHS sources” who think UK-EU trade volumes could be reduced by one-third for months.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has signed a memorandum of understanding (MoU) with its Russian counterpart. The MoU sets the stage for closer collaboration between the agencies, including cooperation on good manufacturing practice (GMP) inspections.

UK-based businesses shipped medicines worth around $1 billion to Russia over the first 11 months of 2018. That made the UK the fourth biggest importer of medicines into Russia after Germany, the United States and France. Having shipped 131 million packages into Russia over the analyzed period, the UK is also the fourth biggest importer by volume.

The extent of trade between the countries makes the UK an important region for Russian authorities. To support its activities in the UK, Russia’s State Institute of Drugs and Good Practices (SID&GP) has entered into a MoU with MHRA that it foresees leading to the development of mutual approaches to GMP inspections. With that goal in mind, SID@GP has invited MHRA to observe its inspections of UK facilities this year.

MHRA and SID&GP also plan to exchange information on the regulation of medicines, share safety information and collaborate on enforcement activities. UK officials think these areas of cooperation will aid with tasks, including the pursuit of criminals.

“Working in an increasingly global environment, the sharing of intelligence between medicines regulators is the cornerstone of protecting the health system worldwide,” Sam Atkinson, director of the inspection, enforcement and standards division, at MHRA said. “Formalizing our already close working relationships with international counterparts helps facilitate this exchange of information.”

UK Recalls More Sartan Products as France Orders Manufacturers to Run Tests

European regulatory agencies are continuing efforts to protect patients from possible impurities in sartans. In the UK, MHRA recalled more batches of irbesartan, while in France authorities ordered sartan manufacturers to ensure products that shipped last year comply with new requirements.

The UK recall affects three batches of the blood pressure drug irbesartan sold by Macleods Pharma. Macleods began the pharmacy-level recall after tests found the batches could be contaminated with N nitrosodiethylamine (NDEA), one of the two impurities that alarmed regulators around the world last year. There is currently no evidence that NDEA has harmed patients.

MHRA’s last two sartan recalls have focused on irbesartan — the previous one affected products sold by Actavis — but it is one of a handful of molecules at risk of contamination with NDEA or another impurity, N-nitrosodimethylamine.

France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé’s (ANSM) recent action is intended to ensure the five sartans sold in the country are free from impurities. AMSM’s action builds on an EU-level requirement for sartan manufacturers to take extra steps to prevent impurities. The French agency has given producers until the end of March to perform the actions.

Germany’s Federal Institute for Drugs and Medical Devices (BfArM) is evaluating 79 bids from groups that want to produce medicinal cannabis. BfArM put out the tender to establish cannabis capacity in Germany, which is currently fully reliant on imports.

To establish local production of medicinal cannabis, BfArM put out a tender for 10,400 kg of cannabis over a four-year period, an amount that is 58% more than planned originally. BfArM is subdividing each annual tender of 2,600 kg into 13 lots of 200 kg in an attempt to enable smaller companies to enter the market and ensure it is not too reliant on a small number of producers.

The tender has attracted a lot of interest. BfArM received 817 offers for the available lots from 79 bidders. The agency, which has a subdivision focused on cannabis, is now evaluating the offers before reaching a decision.

If everything runs to schedule, BfArM thinks the first harvest will take place in the fourth quarter of 2020. BfArM expects importers will continue to serve manufacturers, retailers and pharmacies.

The Committee on the Environment, Public Health and Food Safety (ENVI) has issued an opinion on the parliamentary scrutiny of decentralized agencies such as the European Medicines Agency (EMA). ENVI used the opinion to reiterate its position that the process used to select EMA’s new location “did not constitute a precedent and must not be used again.” ENVI Opinion

MHRA has issued an alert to users of Abbott’s FreeStyle Libre glucose monitoring system. The alert discusses how the use of barrier methods to reduce skin reactions may affect the performance of the device. MHRA Alert